Potential Effect of Selenium, QoL Before and After 9 Month of Medical Treatment of Graves´Thyrotoxicosis
Conditions
Keywords
selenium, neuropsychological testing, autoantibodies
Brief summary
Graves thyrotoxicosis is a common autoimmune disease. Patients suffer at diagnosis from weight loss, increased heart rate and stress intolerance. Some patients have difficulties in regaining quality of life. Diagnosis is found through elevated thyroid hormones thyroxin, suppressed TSH (thyroid stimulating hormone) from the pituitary and elevated stimulatory antibodies, TRAb (thyrotropin receptor antibody) to the thyroid. Selenium is sparse in western Europe. This compound has important function in thyroid hormone metabolism and on the immune system. It is not known whether addition of selenium affects the well being of patients with Graves´thyrotoxicosis. The subject of this study is to investigate this
Detailed description
In the County of Södermanland we include 44 patients with Graves´thyrotoxicosis. They are treated with methimazole and thyroxin, and randomised to selenium or placebo. Neuropsychological investigation is performed, before medical treatment is commenced and repeated after 9 month. Serum concentration of thyroid hormon levels, autoantibodies and selenium are followed.
Interventions
OTHERselenium
200 ug selenium once daily
OTHERplacebo
Sponsors
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* New diagnose of autoimmune thyrotoxicosis * biochemically proven with increased thyroxin * low TSH and elevated TRAb/or positive scintigraphy. * Age 18 - 55. Willing to participate -
Exclusion criteria
* No previous head trauma, * No difficulties with swedish language, * No medication which could affective neuropsychological testing, * No planned or ongoing pregnancies. * Normal intellectual capacity. * No severe ophthalmopathy, or other severe disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effect on neuropsychological well-being | Inclusion going on until the end of 2011 |
Secondary
| Measure | Time frame |
|---|---|
| Potential effect on autoantibodies | Inclusion for the rest of 2011 |
Countries
Sweden
Outcome results
None listed